Agency classClass IIOur severity:High FDA (Devices)·Z-1682-2021·Announced 2021-06-02

Pentax Medical Video Duodenoscope Recalled for Distal End Cap Detachment Risk

Pentax of America Inc. is recalling 108 Pentax Medical Video Duodenoscopes because the distal end cap may detach during procedures, posing risks of injury or aspiration.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of physical injury (mucosal injury, lacerations, bleeding, aspiration) from a medical device component detaching, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pentax of America Inc. is recalling 108 units of the Pentax Medical Video Duodenoscope, Model ED34-i10T2. The recall is due to a risk that the OE-A63 distal end cap may unexpectedly become detached during a procedure. This detachment can result in unforeseen events such as mucosal injury, lacerations, or bleeding of the patient. Additionally, if the detached cap enters the patient's oral cavity, it may result in aspiration.

The affected devices were distributed nationwide in the United States, specifically in Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, and Washington, D.C. The recall covers all units of the specified model.

Pentax of America Inc. has updated the Instructions for Use (IFU) for both the OE-A63 distal end cap and the ED34-i10T2 duodenoscope. These updates notify users of the associated risks with the distal end cap detaching and provide instructions on immediate actions to take if this event occurs. Users should review the updated IFU for safety guidance.

The recalled product

Product: Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number…
Manufacturer: Pentax of America Inc
Category: Medical Device — Endoscope
Hazard: injury
aspiration
Affected units: 108

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All units

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same manufacturer · Pentax of America Inc

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